Healix Anchor is indicated for use in the following: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair: Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular repair, acetabular labral repair.

Device Description

The Healix Anchor is a non-absorbable threaded suture anchor manufactured of polyetheretherketone (PEEK) material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The anchor is provided in three sizes: one with an outer diameter of 4.5mm, another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The suture options may or may not include tapered needles to facilitate suture passage through tissue. The Healix Anchors are currently offered with absorbable Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.

AI/ML Overview

Here's an analysis of the provided text regarding the Healix Anchor, focusing on acceptance criteria and supporting studies:

Based on the provided document, the Healix Anchor is a medical device, and the submission is a 510(k) premarket notification. This type of submission seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that it meets specific, quantitative acceptance criteria through a clinical study.

Therefore, the information you've requested about acceptance criteria and supporting studies, particularly those involving human readers, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance, is not present and not applicable in this context. The document focuses on demonstrating substantial equivalence through technological characteristics and existing performance and safety testing.

Here's a breakdown of what can be extracted from the document in relation to your questions, and where information is inherently missing due to the nature of a 510(k) submission for this type of device:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Acceptance Criteria (Implied by 510(k))	Reported Device Performance (from document)
Intended Use/Indications:	Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.Hip: Capsular repair, acetabular labral repair.
Technological Characteristics:	Non-absorbable threaded suture anchor manufactured of PEEK material. Comes preloaded on a disposable inserter assembly. Intended for fixation of #2 suture to bone. Provided in three sizes: 4.5mm, 5.5mm, and 6.5mm outer diameters. Suture options include absorbable Panacryl, non-absorbable Ethibond, or partially absorbable Orthocord suture.
Safety and Performance:	"Results of performance and safety testing have demonstrated that the Safety and Performance modified device is substantially equivalent to the predicate devices." (No specific metrics or thresholds are provided in this summary document.)
Substantial Equivalence:	"Healix Anchor is substantially equivalent to: Mitek Spiralok Anchor (K041069 and K060271). The Healix Anchor is also similar to the Arthrex Corkscrew FT Anchor (K061863 and K061665) and the Arthrex Biocorkscrew Anchor (K061863 and K043337)." "Based on the indications for use, technological characteristics, and comparison to predicate devices, the Healix Anchor has been shown to be substantially equivalent to predicate devices..."

Missing Information (Not applicable or not typically found in this type of 510(k) summary for a physical medical device)

Sample size used for the test set and the data provenance: This device is a physical bone anchor, not an AI or diagnostic imaging device that uses "test sets" of data as understood in that context. The "testing" referred to is likely mechanical, biocompatibility, and sterilization testing, not performance on data sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI, refers to expert-validated data. For a physical implant, "ground truth" might relate to mechanical strength or biocompatibility standards, and would be established through engineering and biological testing, not expert consensus on images or outcomes.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As stated above, "ground truth" for a physical device would relate to engineering specifications and biocompatibility standards. The document implicitly states that "performance and safety testing" was conducted, but doesn't detail the specific methodologies or "ground truths" used beyond establishing substantial equivalence to predicates.
The sample size for the training set: Not applicable. This is not an AI or machine learning device that requires training data.
How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves Acceptance:

The "study" referenced in this 510(k) summary is not a single clinical trial or a data-driven performance study in the way one might think of for an AI diagnostic device. Instead, it refers to a submission demonstrating substantial equivalence to previously legally marketed devices (the predicate devices: Mitek Spiralok Anchor, Arthrex Corkscrew FT Anchor, and Arthrex Biocorkscrew Anchor).

The proof of acceptance rests on the assertion that:

The indications for use of the Healix Anchor are clearly defined and substantially similar to the predicate devices.
The technological characteristics (materials, design, sizes, suture options) are similar enough to the predicate devices that they do not raise new questions of safety or effectiveness.
Performance and safety testing (not detailed in this summary, but typical for these devices includes mechanical strength, fatigue, biocompatibility, and sterilization validation) has been conducted and demonstrates that the device is substantially equivalent to the predicate devices.

The FDA's decision to clear the device (as indicated in the letter from Mark N. Melkerson) signifies their agreement that the device has met the criteria for substantial equivalence under 21 CFR 888.3040, thereby allowing it to be marketed.

Summary

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14071481 (pg 1/2)

SECTION 2 – 510(k) SUMMARY

Healix Anchor

Submitter's Name andAddress:	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Ruth C. ForstadtProject Management Lead, Regulatory AffairsDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone: 508-977-3988Facsimile: 508-828-3750e-mail: rforstad@dpyus.jnj.com
Name of Medical Device	Classification Name: Fastener, Fixation, Nondegradable, SoftTissue Smooth or threaded metallic bonefixation fasteners
	Common/Usual Name: Bone Anchor
Substantial Equivalence	Proprietary Name: Healix AnchorHealix Anchor is substantially equivalent to:Mitek Spiralok Anchor (K041069 and K060271). The Healix Anchoris also similar to the Arthrex Corkscrew FT Anchor (K061863 andK061665) and the Arthrex Biocorkscrew Anchor (K061863 andK043337).
Device Classification	This device carries an FDA product code MBI and HWC, and isclassified as Fastener, Fixation, Nondegradable, Soft Tissue Smooth orthreaded metallic bone fixation fasteners under 21 CFR 888.3040.
Device Description	The Healix Anchor is a non-absorbable threaded suture anchormanufactured of polyetheretherketone (PEEK) material. The threadedanchor comes preloaded on a disposable inserter assembly and isintended for fixation of #2 suture to bone. The anchor is provided in

Healix Anchor

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KO71481 (pg 212)

three sizes: one with an outer diameter of 4.5mm, another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The suture options may or may not include tapered needles to facilitate suture passage through tissue. The Healix Anchors are currently offered with absorbable Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.

The Healix Anchor is intended for: Indications for Use Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair: Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular repair, acetabular labral repair. Results of performance and safety testing have demonstrated that the Safety and Performance modified device is substantially equivalent to the predicate devices. Based on the indications for use, technological characteristics, and comparison to predicate devices, the Healix Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

Premarket Notification: Traditional Healix Anchor

Confidential

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a bird or a human figure with flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Mitek a Johnson & Johnson Company % Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs 325 Paramount Drive Raynham, MA 02767

AUG - 9 2007

Re: K071481

Trade/Device Name: Healix Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, HWC Dated: May 25, 2007 Received: May 29, 2007

Dear Ms. Forstadt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Ms. Ruth C. Forstadt

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehrig

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): _ ½07 |48|

Device Name: Healix Anchor

Healix Anchor is indicated for use in the following:

Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular repair, acetabular labral repair.

Prescription Use

Over-the -Counter Use (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buelher for MHM
(Division Sign-Off)

and Neurological Devicest

510(k) Number K071481

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.